Compliance with confidence

Welcome to Brandwood CKC, a trusted regulatory partner to the biomedical industries for more than 20 years. Our team's deep expertise, international network and proven strategic approach can help you successfully navigate the pathways to global market access.

How we can help your business

Brandwood CKC offers a wide range of regulatory, technical and commercial services to partner your business and your product to success in Australia, New Zealand and the broader global markets of Asia-Pacific, North America and Europe.

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Make your next step the right step

Let us show you how our proven strategic approach can open your global markets.

Biomedical Industry Updates

Biomedical news, views, insights and case studies from across the globe.

Standards

Are Harmonised Standards facing irrelevance?

There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR).  And rightly so. But...
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The question on clients’ lips… “How long will my application take?”

Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, The TGA released...
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TGA Publishes updated MDIR Guide

Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events...

Let Us Know What You Think

If you've got any questions or would just like to learn more about what how we could work together, then get in touch.

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